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Wegener Granulomatosis clinical trials

View clinical trials related to Wegener Granulomatosis.

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NCT ID: NCT01933724 Active, not recruiting - Vasculitis Clinical Trials

The Assessment of Prednisone In Remission Trial (TAPIR) - Patient Centric Approach

TAPIR
Start date: February 17, 2014
Phase: Phase 3
Study type: Interventional

This is a randomized controlled trial in patients with a diagnosis of granulomatosis with polyangiitis (GPA; Wegener's)that are in remission to evaluate the effects of using low-dose glucocorticoids ( 5 mg/day of prednisone) as compared to stopping glucocorticoid treatment entirely (0 mg/day of prednisone)on rates of disease relapse/disease flares. This study is a novel approach to conducting a randomized clinical trial in the community setting. This study is being conducted in parallel with a similar study at established vasculitis institutions. This study will have a patient centric approach to research in that subjects will be recruited online and through social media and vasculitis support networks. Participants will be consented online and will receive care through their regular treating physician so no travel or additional doctor visits are required. Study participants will consent to the study and complete online questionnaires about their prednisone dose and about how they are feeling.

NCT ID: NCT01729624 Active, not recruiting - Clinical trials for Microscopic Polyangiitis

PRO Development for ANCA Associated Vasculitis

Start date: September 2012
Phase: N/A
Study type: Observational

A qualitative study using interviews with patients who have antineutrophil cytoplasm antibody (ANCA) associated vasculitis, to develop a patient reported outcome (PRO)measure

NCT ID: NCT01697267 Completed - Clinical trials for Microscopic Polyangiitis

Rituximab Vasculitis Maintenance Study

RITAZAREM
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Rituximab is now established as an effective drug for anti-neutrophil cytoplasmic antibody (ANCA) vasculitis following major European and US trials reported in 2010. After a time, its effect wears off and the disease can return. This occurs in at least half of patients within 2 years of receiving Rituximab. A preliminary study in Cambridge has suggested that repeating rituximab every six months stops the disease returning and is safe. The RITAZAREM trial will find out whether repeating rituximab stops vasculitis returning and whether it works better than the older treatments, azathioprine or methotrexate. It will also tell us how long patients remain well after the repeated rituximab treatments are stopped, and if repeated rituximab is safe. We should also learn useful information about the effects of rituximab on quality of life and economic measures. The trial results will help decide the best treatment for future patients who have their vasculitis initially treated with rituximab. RITAZAREM aims to recruit patients with established ANCA vasculitis whose disease has come back 'relapsing vasculitis'. All patients will be treated with rituximab and steroids and we anticipate that most will respond well. If their disease is under reasonable control after four months, further treatment with either rituximab (a single dose ever four months for two years) or azathioprine tablets will be chosen randomly. The patients in the rituximab and azathioprine groups will then be compared. Patients will be in the trial for four years. The study has been designed by members of the European Vasculitis Study group (EUVAS) and the Vasculitis Clinical Research Consortium (VCRC). It will include 190 participants from 30 hospitals in Europe, the USA, Australia and Mexico. RITAZAREM is being funded by Arthritis Research UK, the U.S. National Institutes of Health and by Roche/Genentech.

NCT ID: NCT01598857 Withdrawn - Clinical trials for Microscopic Polyangiitis

BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis

BIANCA-SC
Start date: December 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel Vasculitis.

NCT ID: NCT01446211 Terminated - Clinical trials for Wegeners Granulomatosis

Clinical Study Comparing the New Immunosuppressive Drug Gusperimus With the Conventional Treatment in Wegener's Granulomatosis

SPARROW
Start date: November 2011
Phase: Phase 3
Study type: Interventional

The aim of the study is to assess the efficacy (superiority testing) of gusperimus compared to conventional treatment in patients with a relapse of Wegener Granulomatosis with or without ongoing steroids, and/or immunosuppressive therapy. Further, to evaluate the safety and quality of life of gusperimus treatment compared to standard treatment in patients with relapse of Wegener Granulomatosis receiving glucocorticoids.

NCT ID: NCT01408836 Terminated - Clinical trials for Microscopic Polyangiitis

Plasma Exchange for Renal Vasculitis

MEPEX
Start date: March 1995
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to test whether additional therapy with plasma exchange improves the chances of kidney recovery in severe kidney vasculitis.

NCT ID: NCT01405807 Recruiting - Vasculitis Clinical Trials

Alemtuzumab for ANCA Associated Refractory Vasculitis

ALEVIATE
Start date: February 2011
Phase: Phase 4
Study type: Interventional

Overview: This open label, randomized, multi-centre study will enroll and treat 24 patients with refractory AAV. Aims: To determine the clinical response and severe adverse event rates associated with alemtuzumab therapy among patients with relapsing or refractory ANCA associated vasculitis (AAV). Hypothesis: Treatment with alemtuzumab induces sustained remission in AAV and will reduce immunosuppressive and steroid exposure.

NCT ID: NCT01167491 Completed - Clinical trials for Wegener's Granulomatosis

Study of One Protein Implicated in Wegener Disease

DAP12WEGENER
Start date: May 2010
Phase: N/A
Study type: Interventional

The investigators recently showed an abnormal expansion of NK-like CD4+ T cells in Wegener's granulomatosis (WG), mainly in the diffuse vasculitis presentation. These cells expressed an assortment of activating NK cell receptors and their signaling partners, in particular DAP12. The investigators hypothesize that DAP12, or a downstream signaling target of DAP12, is the missing link between the different cell components involved in WG (neutrophils, macrophages, CD4 T cells).

NCT ID: NCT00753103 Completed - Clinical trials for Microscopic Polyangiitis

Anti-Cytokine Therapy for Vasculitis

ACTIVE
Start date: January 2003
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Infliximab (monoclonal anti-tumour necrosis factor alpha antibodies) are safe and effective in the treatment of anti-neutrophil cytoplasm antibody (ANCA) associated vasculitis.

NCT ID: NCT00751517 Active, not recruiting - Clinical trials for Microscopic Polyangiitis

Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides

Start date: n/a
Phase: Phase 2
Study type: Interventional

The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.